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If you have read any of my articles before, you know I specialize in sharing my knowledge and experience in the water garden business over the past 26 years. Because I don’t own or promote a water garden su

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

pply store, I can therefore present unbiased and balanced information – whether it is advice on the best construction methods for a water garden, or which models of U.V. or pump have the best warranties or t

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

e are the most energy efficient.

I have shared with you before about the incredible financial benefits of offering clients digital designs. Even if you are a do-it-yourselfer homeowner, a digital design is

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

a low-cost and effective way to get your ideas and vision across in a brilliant, vivid, virtually real way. It is the most important first step of any water garden project.

For several years now I have be

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

n presenting virtual designs to my customers. Googling “digital design ponds” or “digital design water gardens” will result in seven cad cam or 3D-type design programs. These types of software produce stil

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ted, unnatural, unrealistic results. In the past 26 years I have designed and constructed well over 1,900 water gardens for commercial and residential clients. Until recently, most of these designs were pr

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

duced the “old fashioned” way, by hand drawing them.

Unless the architect is an artist, their drawing is generally a floor plan with an accompanying side view of individual components or features. The end

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

result would be that the client does not have a realistic view of the proposed project.

Another negative aspect of the old way of doing things is the investment of time in making the drawing. Consequently,

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

I had to charge $500 to $2,500 for a design drawing.

A few years ago I discovered that I could scan various water garden photos, then download them into Adobe’s Photoshop program, and cut out objects or por

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

tions out of the photographs. By downloading a photo into Photoshop, I could then take these “jpg” cut-outs such as rocks, plants, portions of waterfalls and ponds, into the photo. By moving the item aroun

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

, resizing, cloning and adjusting various aspects, I could create a virtual realistic and natural water garden that would look the actual photo of a completed project.

Soon, by repeating this process one ob

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ject at a time, I created a Library of water garden related images that allowed me to create thousands of variations of an actual water garden design. Amazingly, 8 out of 10 prospective clients paid me $350

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

to get a digital water garden design of their back yard. It was not long before I could produce a design in as little as 15 minutes, with the average being about one hour.

My clients can now see exactly wh

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

at they are getting with no confusion, misunderstandings or misconceptions, such as those you could get from a typical hand-drawn architectural floor plan. Plus, the client has a specific water garden desig

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

photo with which to procure additional bids. I tell the client that if they go with me, I will deduct the $350 from the labor cost of the proposal. However, if they decide not to hire me, I have been comp

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ensated for what little time I have invested in this sales call. In most cases the client is so impressed with my digital design, they opt to go with me. This design program has increased my closing ratio

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

y 38% be setting me apart from my competition.

Photoshop currently costs $700 to purchase, and has a very long learning curve. I discovered a program for only $129, “Microsoft Digital Image Suite.” It pro

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

duces similar results as Photoshop for a fraction of the investment of both money and time learning it. It is amazing how such a small investment can bring such a large return! If you decided to create thr

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

e to four designs a day, it would probably only take you half a day. Working five days per week, this would give you an annual income of over $300,000 per year! To show how this is done, I have placed a pr

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

esentation video and demo video with sample designs on the internet for your convenience at: http://www.watergardenauthority.com/Digital_Design.html

There are other helpful free articles at ezinearticle.co

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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